In our August's FSMA Fridays session with David Acheson of The Acheson Group we continued the previous month's focus on environmental monitoring and environmental control programs. Dr. Acheson answered pre-submitted questions from session attendees.
What's New at the FDA? Guidance for Seafood, Juice, and Low-Acid Canned Foods
Dr. Acheson reviewed some of the recent goings on at FDA, including the launch of Food Safety Plan Builder (FSPB), a new tool geared towards smaller businesses that was developed to help companies build food safety plans that meet the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.
Another recent development at FDA is three new guidance documents which are focused on some of the major issues around the exemptions, or lack thereof, for those in the seafood industry, juice industry, and low-acid canned foods. Dr. Acheson pointed out that some of the major exceptions for FSMA Preventive Control Rule compliance were those under Juice HACCP and under Seafood HACCP. There are also some exceptions for companies under the LACF, Low-Acid Canned Food regulatory requirements. According to Dr. Acheson, these guidance documents have really gone through FSMA and laid out what they, the FDA, is expecting you to do. He added, "There are components around the GMPs that you need to make sure that you're current with the new requirements as opposed to the old requirements. The fundamentals on the Preventive Control Rule, hazard analysis and all of that, is indeed, that is exempt because the HACCP programs are designed to cover that." He added that if you're in that space and you have been working under the notion of, 'Well, FSMA just doesn't apply to me,' then you've been wrongfully informed. He encouraged companies in seafood, juice, and low-acid canned foods spaces to take a look at the guidance documents, adding, "Just make sure that you are tracking with what you're supposed to do so that you're not going to fall on the wrong side of a regulator."
That's a Great Question About Environmental Monitoring!
Dr. Acheson fielded some great questions from our attendees, among them:
"Can you talk through a definition of 'ready-to-eat', and is raw flax seed a ready-to-eat product?"
"How might FDA react to a persistent non-L. mono listeria species if data supports the die-off for listeria in the product? Does that make this product a lower risk?"
"What if we make a low risk product in aspect of water activity of less than 0.6? Do we need to conduct environmental monitoring?"
Check out the recording from the August FSMA Fridays session for his answers to these questions and more!
Join Our Next FSMA Fridays Session: September 29
Save the date for an extended session at 9:00 a.m. Friday, September 29, when we will review current developments pertaining to FSMA and discuss results from the 2017 Food Safety and Quality Operations Survey! Register for our monthly series at www.FSMAFridays.com.
The Conversation Continues on the FSMA Fridays LinkedIn Group
Our LinkedIn group has grown steadily over the months to many new members—we are now over 180 members strong! Group participation offers opportunities for peer discussion, access to additional FSMA Fridays session content, and engagement in valuable dialogues around the management of FSMA compliance. Join the LinkedIn group today!